MTPConnect – the Australian Government’s Medical Technology, Biotechnology, and Pharmaceutical (MTP) Industry Growth Centre – and the Minister for Health, the Hon Greg Hunt MP, today announced the first 11 recipients of $10 million investment from the Australian Government’s $35 million BioMedTech Horizons program. The program aims to help Australia move more cutting-edge ideas and breakthrough discoveries towards proof-of-concept and commercialisation, and stimulate collaboration across disciplines and between the research, industry and technology sectors to maximise entrepreneurship and idea potential.

Investments from the
program are focused on precision medicine and 3D anatomical printing. Successful
projects in this first round include a fully synthetic 3D printed spinal cage,
a genome profiling platform to enable precision cancer medicine, a wireless
Brain-Machine Interface suitable for treating neurological disorders, and microwearables
for precision medicine.

Sue MacLeman, Managing
Director and CEO of MTPConnect, said that the delivery of the BioMedTech
Horizons program is providing the necessary support to boost investment,
commercialisation and success of health innovations in Australia.

"These first
investments from the BioMedTech Horizons program are set to fuel ongoing innovation
in Australia, in line with MTPConnect's priorities for growth of the medical
technology, biotechnology and pharmaceutical sector. These 11 outstanding
projects address identified global megatrends including precision healthcare
and the digital evolution, as well as forecasted areas of unmet clinical need,
such as immunology, advanced prosthetics and infectious diseases including
sepsis.

“Australia is an internationally recognised hub of health innovation, but it has been acknowledged that more work needs to be done in providing support at the pre-clinical and clinical stages of development, to assist in attracting private capital during early stages. MTPConnect is dedicated to working with the sector to ensure growth in collaboration between research and industry, to drive greater commercialisation. The BioMedTech Horizons program is set to address barriers of funding to support viable, new health biological and medical technologies to reach proof-of-concept, clinical trials and beyond, in line with our vision to advance the vibrant sector.”

Minister for Health, the Hon Greg Hunt MP, said, “The Turnbull Government is committed to improving the health services for all Australians and will continue to invest in better treatment, care and medical research. Our researchers are innovators and this investment will speed up the journey from idea to reality. These technologies have the potential to create better health outcomes for Australians, while driving investment and strengthening our economy. All Australians benefit from investment in health and medical research.”

The BioMedTech Horizons program is being delivered as a part of the Australian Government’s $20 billion Medical Research Future Fund, which aims to transform health and medical research to improve lives, build the economy and contribute to health system sustainability through targeted strategic investment.

The BioMedTech Horizons program attracted an extremely strong response from the sector with 219 expressions of interest submitted. The applications were reviewed by an experienced selection panel comprising of scientific, clinical and commercial experts, and 30 projects were shortlisted. Due to the overwhelming number of high quality submissions, and consistent with the Australian Government’s agreement with the Medical Technology Association of Australia which includes a $30 million boost to support development of new and innovative device technologies, the Australian Government has committed an additional $5 million to support 11 of the 30 shortlisted projects.

Ian Burgess, CEO of the Medical Technology Association of Australia, said, “We’re pleased our agreement with the Government has provided an additional $30 million towards the BioMedTech Horizons program. Australian MedTech has been responsible for some of the most significant medical developments of the past 100 years. With an aging population comes major challenges for our health sector. MedTech will play a vital role in tackling these challenges and these 11 recipients, with a focus on precision medicine and 3D anatomical printing, will contribute towards improved health outcomes.”

Established as part of the Australian Government’s Industry Growth Centres Initiative, MTPConnect aims to accelerate the growth of the MTP ecosystem in Australia by working with the sector to increase its competitiveness, productivity and innovative capacity. MTPConnect was chosen to administer and facilitate the delivery of funding due to its proven fund management experience through the MTPConnect Project Fund Program, and established cross-sectoral networks and connections, providing the ability to rapidly identify and invest in new technologies. MTPConnect will continue its work with the sector to support initiatives addressing identified barriers to growth in the sector, increasing the number of innovations to reach proof of concept and clinical trials in key knowledge priority areas.

The 11 projects selected for the initial $10 million BioMedTech Horizons program investment are listed below:

Development of a 3D printed graft for surgical repair of the Scapholunate Interosseous wrist ligament (SLIL)Griffith University, Orthocell, University of Western Australia, Queensland University of TechnologyA novel strategy with a personalised bone-ligament-bone graft using 3D printed biocompatible scaffolds is set to create positive results for sufferers of Scapholunate Interosseous Ligament (SLIL) injury, the most common of wrist ligament injuries. SLIL injuries cause dislocation of scaphoid and lunate bones and can be career-ending for an athlete and result in long-term disability for others. Typically, SLIL injuries are surgically treated, but have poor prognosis, with patients developing functional limitations and severe hand/wrist osteoarthritis, which impairs long-term health and imposes substantial economic burden. This project will support pre-clinical research and development to enable Orthocell to start human clinical trials, seek regulatory approval and commercialise.

B3D Cervical Interbody Fusion DeviceAllegra Orthopaedics, University of Sydney, University of Wollongong, Boron Molecular, Sabre MedicalThe Allegra Orthopaedics fully synthetic spinal cage works to regenerate bone under spinal load conditions and be completely resorbed by the body, leaving it and the intervertebral space free of foreign materials – making it a one-of-a-kind innovation. The device is 3D-printed from a synthetic bone bioceramic (Sr-HT-Gahnite) invented at The University of Sydney. The synthetic bone possesses the mechanical strength required for load-bearing conditions, bioactivity needed for outstanding bone regeneration, and resorbability that reduces the risk of rejection and infection – all in a customisable structure. No bone graft is required as the device material induces bone graft. This project will provide the necessary funding for device production for preclinical testing.

BioPenThe University of Melbourne, St Vincent’s Hospital Melbourne, University of Wollongong, Swinburne University of TechnologyThe BioPen is set to provide the first in-situ bioprinting treatment for cartilage injuries, developed at the St Vincent’s Hospital Melbourne biofabrication facility, BioFab3D@ACMD. Cartilage injuries occur in two thirds of all joint trauma, with many leading to osteoarthritis that cannot be adequately prevented or treated using current complex surgery interventions. The BioPen project is working to accurately repair the joint injury, by rapidly isolating stem cells from a patient, loading these into a gel scaffold then printing new cartilage using a hand-held device directly into the defect. The combination of stem cell technology, engineering and surgical innovation promises to simplify surgery through a one-off surgical procedure with the capacity to bank cells for future use if repeat surgery is required. The BioMedTech Horizons funding will enable this project to advance a prototype device, methodologies and bio-ink formulations towards a commercialisable therapy.

CAR-T immunotherapies for solid cancersCarina Biotech, Seattle Children’s Research Institute, The University of Adelaide, Women’s and Children’s Hospital Adelaide, CTM@CRCChimeric Antigen Receptor T-cell (CAR-T) therapy is an individually customised approach to cancer treatment that genetically engineers a patient’s own immune cells to react to a specific molecular marker on their cancer. CAR-T therapy has shown extraordinary efficacy against blood cancers, however solid cancers have been less responsive to CAR-T therapy to date. Carina Biotech has produced CAR-T cells targeted to a solid cancer molecular marker, which has been published as present in many solid cancers, while having no expression on healthy cells. BioMedTech Horizons investment will allow Carina to work to achieve in-vivo proof of concept for its CAR-T cells across multiple animal models of human solid cancer.

A clinically-accredited and commercial-ready genome profiling platform to enable precision cancer medicineGarvan Institute of Medical Research, Genome.One, IlluminaPrecision cancer medicine is set to transform the clinical trial industry, with international trials attracting heavy investment. This next generation of clinical trials requires fast, comprehensive and cost-effective genomic profiling of patient tumours. The FDA recently approved two US cancer genomic tests, however, their cost (AU$5,500) is prohibitive for routine use in Australia and their matching to US-approved drugs and trials are of limited utility to Australians. Offshore testing also fails to develop necessary domestic infrastructure for precision cancer clinical trials. The genome-profiling platform for precision cancer medicine is set to include a clinically-accredited tumour profiling test and a cancer genomics data platform that incorporates a national patient matching system for precision cancer clinical trial access. It aims to provide competitively priced and rapid local testing. These solutions work to ensure that, in the face of increasing global capabilities and investment in precision cancer clinical trials, Australia will remain an attractive trial site and leader in precision medicine.

EarGenie: Personalised management of hearing impairment for infantsBionics Institute, Hydrix, Taralye Early intervention Centre, Plunkett Consulting Group, Australian HearingEarGenie is an innovative system for personalised management of hearing impairment, aiming to enable life-long benefits using a novel combination of electrophysiology and functional near-infrared spectroscopy (fNIRS) to perform a diagnostic hearing evaluation. Deaf infants face delayed and inadequate language development, affecting education, social participation, and even employment later in life. Major contributing factors are the delay between diagnosis and the selection and accurate adjustment of hearing devices, delayed individualised optimisation of device features, and difficulty choosing a specific therapy to optimise language development. EarGenie is set to transform the precision of diagnosis and optimisation of hearing instrument function, to deliver major benefit to language development in deaf children. This project will allow for the development of a clinical prototype as well as plans for regulatory approval and clinical trials.

Gennaris Neural Systems (GNS)Monash University, Alfred Health, MiniFABMonash Vision Group (MVG) has developed a wireless Brain-Machine Interface (BMI) offering the potential to bypass damage to nerves and neural pathways, restoring function to affected areas of the brain. MVG’s Brain-Machine Interface has been implemented in a cortical vision prosthesis that is designed to bypass damage to the visual pathway and restore basic vision. This funding will assist the transition between preclinical and clinical programs, allowing the utility of the visual prosthesis to be demonstrated. A company will be established to manufacture MVG’s Brain-Machine Interface and commercialise the visual prosthesis. The aim of this company is to bring the product to market by 2021 to address the unmet need of a treatment for complete blindness. MVG’s cortical vision prosthesis has been designed to treat a range of blindness causes, such as glaucoma and optic nerve damage, which are not suitable for retinal implants. The successful commercialisation of this technology will establish Australia as an exporter of implantable medical devices, and global market leader in BMI manufacturing.

Microwearables: Leaping towards precision medicineWearOptimo, The Australian National University, Queensland Government, Australia National Fabrication FacilityMicrowearables (simple, wearable devices) have the opportunity to be a cornerstone of precision medicine by offering personalised diagnostics across a range of diseases. These devices are minimally-invasive, pain-free sensors applied to the skin to access key biomarkers and biosignals – for both episodic and continuous monitoring. In doing so, Microwearables aim to leapfrog traditional diagnostics: based on lab-based assays of blood samples and histopathology – with the costs, risks and time-delays. WearOptimo will be developed as a fit-for-purpose enterprise to rapidly compete at scale, meeting the unique opportunity at the nexus of three growing markets: IoT for medicine; personalised medicine; and wearable devices for healthcare. Led by Professor Mark Kendall and in partnership with the Australian National University (ANU), this project will take the next critical step in working to advance Microwearables into an enterprise – that is commercial, with technical proof-of-concept, and is investor ready.

3D Printing and the Manufacture of ‘PoreStar’ – a novel Porous Polyethylene Implant MaterialAnatomicsIn 2014, Anatomics, in conjunction with CSIRO and Australian universities, developed a breakthrough porous high-density polyethylene implant material, PoreStar. PoreStar’s material advantages include its superior tensile and flexural strength avoiding cracks when bent, the ability to use fixation screws very close to the implant margins without material breakage, and a unique scaffold architecture that facilitates tissue ingrowth. This project aims to advance the state-of-the-art in pHDPE craniomaxillofacial (CMF) implant manufacturing, leveraging 3D printing to reduce process complexity, product turnaround time and cost of goods. Moreover, the project seeks to improve surgical practice by extending the use of temporary implants to patient-specific CMF surgeries, and develop improved software solutions for surgical planning and preoperative estimation of cosmesis, aiming to reduce complications and reoperation rates for CMF surgeries.

Rapid diagnostic for the pathogens that cause sepsisBiotech Resources, Monash University Centre for Biospectroscopy, The Alfred Hospital, Monash Health, HydrixBiotech Resources (BTR) is working to develop the world’s first rapid diagnostic test ‘Aimalux’ for the direct detection of the bacteria and fungi that cause sepsis from whole blood. The technology and platform has been developed by the Monash University Centre for Biospectroscopy in Melbourne Australia. Sepsis is a life-threatening disease that results in the deaths of over 6 million people every year around the world, and more than 5,000 Australians. It is time critical medical emergency. Every hour without treatment increases a patient's chance of dying by 7.6%. And yet there is no definitive test for sepsis with more than 30% of cases going misdiagnosed. If the symptoms of Sepsis are missed and treatment is not administered, then this can result in patient death. This also means that many patients are treated unnecessarily as a precaution, which has its own detrimental consequences as well as adding to the rise of antibiotic resistance super bugs. Aimalux aims to provide a diagnostic result within 35 minutes, to revolutionise the way sepsis is currently diagnosed, reduce healthcare costs, and save lives.

Towards bedside gene therapies: Development of a microfluidic gene delivery device for immune cell modification and optimisation for clinical useIndee, University of South Australia Future Industries Institute, Main Sequence Ventures, Defence Science Technologies Group, University of Sydney, Becton DickinsonPioneering cures for terminally ill patients, with conditions including many forms of cancer, are now available thanks to a new generation of treatments called gene-modified cell therapies (GMCTs). Indee Labs plans to make GMCTs accessible to the masses by solving manufacturing issues responsible for their high price tags. It also aims to reduce the lead times for a treatment from months to weeks, saving the lives of patients with aggressive conditions. Gene delivery to cells is the most critical and problematic step in manufacturing GMCTs. This project aims to develop the only practical gene delivery technology, microfluidic vortex shedding (µVS), into a product that will be trailed by pharmaceutical companies. µVS will offer revolutionary improvements over existing gene delivery methods including high yield, negligible immune cell perturbation along with rapid processing of research, clinical- and commercial-scale samples with a simple workflow and a small footprint.